Country: Холандија
Језик: Холандски
Извор: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TEMOZOLOMIDE 100 mg/stuk
Alvogen IPCo S.ar.l 5, rue Heienhaff 1736 SENNINGERBERG (LUXEMBURG)
L01AX03
TEMOZOLOMIDE 100 mg/stuk
Capsule, hard
AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT, AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT (E468) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT,
Oraal gebruik
Temozolomide
Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); LACTOSE 0-WATER; NATRIUMZETMEELGLYCOLAAT (E468); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TITAANDIOXIDE (E 171); WIJNSTEENZUUR, (L (+) Vorm) (E 334); ZWARTE INKT;
2012-11-13
04/2022 MAT NL 26 PACKAGE LEAFLET 04/2022 MAT NL 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BLASTOMAT 5 MG, HARDE CAPSULES BLASTOMAT 20 MG, HARDE CAPSULES BLASTOMAT 100 MG, HARDE CAPSULES BLASTOMAT 140 MG, HARDE CAPSULES BLASTOMAT 180 MG, HARDE CAPSULES BLASTOMAT 250 MG, HARDE CAPSULES temozolomide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Blastomat is and what it is used for 2. What you need to know before you take Blastomat 3. How to take Blastomat 4. Possible side effects 5. How to store Blastomat 6. Contents of the pack and other information 1. WHAT BLASTOMAT IS AND WHAT IT IS USED FOR Blastomat contains a medicine called temozolomide. This medicine is an antitumour agent. Blastomat is used for the treatment of specific forms of brain tumours: - In adults with newly-diagnosed glioblastoma multiforme. Blastomat is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment). - In children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Blastomat is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BLASTOMAT DO NOT TAKE BLASTOMAT - If you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6). - If you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC). Signs of allergic reaction includ Прочитајте комплетан документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 04/2022 MAT NL 2 1. NAAM VAN HET GENEESMIDDEL Blastomat 5 mg, harde capsules Blastomat 20 mg, harde capsules Blastomat 100 mg, harde capsules Blastomat 140 mg, harde capsules Blastomat 180 mg, harde capsules Blastomat 250 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg temozolomide. Each hard capsule contains 20 mg temozolomide. Each hard capsule contains 100 mg temozolomide. Each hard capsule contains 140 mg temozolomide. Each hard capsule contains 180 mg temozolomide. Each hard capsule contains 250 mg temozolomide. Excipient with known effect: Each 5 mg hard capsule contains 399.3 mg of anhydrous lactose. Each 20 mg hard capsule contains 384.3 mg of anhydrous lactose. Each 100 mg hard capsule contains 61.7 mg of anhydrous lactose. Each 140 mg hard capsule contains 86.4 mg of anhydrous lactose. Each 180 mg hard capsule contains 111.1 mg of anhydrous lactose. Each 250 mg hard capsule contains 154.3 mg of anhydrous lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. 5 mg hard capsules The hard gelatin capsules are size 0 and have a green opaque cap/ white opaque body with “5” printed in black ink on the body. 20 mg hard capsules The hard gelatin capsules are size 0 and have an orange opaque cap/ white opaque body with “20” printed in black ink on the body. 100 mg hard capsules The hard gelatin capsules are size 0 and have a purple opaque cap/ white opaque body with “100” printed in black ink on the body. 140 mg hard capsules The hard gelatin capsules are size 0 and have a blue opaque cap/ white opaque body with “140” printed in black ink on the body. 180 mg hard capsules The hard gelatin capsules are size 0 and have a chocolate brown opaque cap/ white opaque body with “180” printed in black ink on the body. 250 mg hard capsules The hard gelatin capsules size 0 and white opaque cap /white opaque body with “250” printed in black ink on the body. 04/2022 MAT NL 3 4. Прочитајте комплетан документ